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The purpose of this study is to evaluate the efficacy TONKA on the reduction of ALT and AST in moderate to severe liver enzyme elevated patients; compared with Silymarin (Legalon) after 6 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TONKA | Experimental | Administered orally twice a day, 2 tablets each time, for 6 weeks |
|
| LEGALON | Active Comparator | Administered orally three times a day, two tablets each time, for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TONKA | Drug | Administered orally twice a day, 2 tablets each time, for 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with ALT reduced to less than or equal to 60 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of patients with ALT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks | |
| The percentage of patients with ALT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) |
| Measure | Description | Time Frame |
|---|---|---|
| The absolute change after treatment discontinuation from week 6 to week 10 in ALT , compared between Tonka and Silymarin (Legalon) | week 6, week 10 | |
| The absolute change after treatment discontinuation from week 6 to week 10 in AST , compared between Tonka and Silymarin (Legalon) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Phuong Tran, BA | Contact | 84.72.3817 117 | lienhe@nhatnhat.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hue Central General Hospital | Recruiting | Huế | Vietnam |
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| ID | Term |
|---|---|
| D048550 | Hepatic Insufficiency |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012838 | Silymarin |
| ID | Term |
|---|---|
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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Block randomization
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| LEGALON |
| Drug |
Administered orally three times a day, two tablets each time, for 6 weeks |
|
| 6 weeks |
| The percentage of patients with AST reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with AST reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with GGT reduced to less than or equal to 40 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with GGT reduced to less than or equal to 40 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with Total Bilirubin reduced to less than or equal to the upper normal limit (UNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with ALT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with ALT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with AST reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with AST reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with GGT reduced to less than or equal to 80 U/L after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with GGT reduced to less than or equal to 80 U/L after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 3 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The percentage of patients with Total Bilirubin reduced to less than or equal to the 2 times of the upper normal limit (2xUNL) after 6 weeks of treatment, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The absolute change from Baseline to 3 weeks in ALT, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The absolute change from Baseline to 6 weeks in ALT, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The absolute change from Baseline to 3 weeks in AST, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The absolute change from Baseline to 6 weeks in AST, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The absolute change from Baseline to 3 weeks in GGT, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The absolute change from Baseline to 6 weeks in GGT, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The absolute change from Baseline to 3 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) | 3 weeks |
| The absolute change from Baseline to 6 weeks in Total Bilirubin, compared between Tonka and Silymarin (Legalon) | 6 weeks |
| The number of participants with other clinically significant laboratory parameters at week 6, compared between Tonka and Silymarin (Legalon). | 6 weeks |
| The number of participants with clinically significant vital sign parameters at week 6, compared between Tonka and Silymarin (Legalon). | 6 weeks |
| week 6, week 10 |
| The absolute change after treatment discontinuation from week 6 to week 10 in GGT , compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
| The absolute change after treatment discontinuation from week 6 to week 10 in Total Bilirubin, compared between Tonka and Silymarin (Legalon) | week 6, week 10 |
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |